Chronic Obstructive Pulmonary DiseaseNCT05918731
Self-management in Chronic Obstructive Pulmonary Disease (COPD) Patients Compared to Usual Care
A study testing Self Management in people with Chronic Obstructive Pulmonary Disease, run by University of Crete at 1 site in Greece.
Trial summary
Evaluation of the effectiveness of COPD self-management interventions compared to usual on Quality of life, functional status, patient education, depression, and anxiety in primary healthcare users in the prefecture of Heraklion, Greece. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Self Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteGreece
- Study dates
- 1 Apr 2020to 30 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients aged ≥18 years
- had previously been given a physician-diagnosis of mild COPD
- stable on their medications (no treatment modifications) in the last three months
- able to speak, read and/or understand Greek
Who cannot join
- refusal to participate
- concurrent oncological diseases
- severe cognitive impairment
- neurological, or psychiatric disability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Self-management in Chronic Obstructive Pulmonary Disease (COPD) Patients: A Primary Healthcare Intervention Study
Evaluation of the effectiveness of COPD self-management interventions compared to usual on Quality of life, functional status, patient education, depression, and anxiety in primary healthcare users in the prefecture of Heraklion, Greece.
Read the detailed description
To the best of our knowledge, no previous study has examined the effects of self-management programs on patients with COPD in Greece. Therefore, the investigators conducted a randomized controlled trial with a post-test design, to evaluate the implementation and clinical effectiveness of a COPD self-management intervention compared to usual care in terms of the following outcomes: Quality of life, functional status, patient education, depression, and anxiety.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Self Management
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self ManagementBehavioural
A "training book" was given to this group, which was created for the study. The implementation process followed a five-step approach including sessions once a month for five consecutive months with a coach and follow-up phone calls after the end of the sessions.To inspire and engage patients, the sessions included a variety of educational techniques, including knowledge transfer, discussion, hands-on training, and homework. Additionally, coaches received training in motivational interviewing methods. The self-management program and all the process of data collection is described in detail on the supplementary file.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care Group | No intervention | Patients who were assigned to receive usual care were instructed to continue up with their regular medical appointments and their usual check-ups/reviews and if they had any questions, to call the health coach. |
| Self-management Intervention Group | Active comparator | In the intervention group, a self-management program was implemented. Receives: Behavioral: Self Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessement of Quality of life
Assessment of the potential effect of self-management intervention on Quality of life using Short-Form Health survey (SF-12) questionnaire. The SF-12 is one of the most widely used instruments for assessing self-reported health-related quality of life. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning
Measured: 6 months
Assessment of Functional status
Assessment of the potential effect of self-management intervention on functional status using COPD Clinical Questionnaire (CCQ) for clinically evaluating COPD.The Clinical COPD Questionnaire (CCQ) measures health status and can be used to assess health-related quality of life (HRQL). The overall CCQ consists of 10 items that are scored from 0 to 6. The final score is the sum of all items divided by 10. Higher scores indicate a worse health status.
Measured: 6 months
Assessment of Depression
Assessment of the potential effect of self-management intervention on depression using Beck Depression Inventory, 2nd edition (BDI).The Beck Depression Inventory (BDI) is a 21-item self-reporting questionnaire for evaluating the severity of depression in normal and psychiatric populations.Scores range from zero to 60. Higher total scores indicate more severe depressive symptoms.
Measured: 6 months
Assessement of Anxiety
Assessment of the potential effect of self-management intervention on anxiety using Beck Anxiety Inventory (BAI). The BAI is a rating scale used to evaluate the severity of anxiety symptoms. The total score ranges from 0 to 63, with higher scores indicating more severe anxiety symptoms.
Measured: 6 months
Assessement of Patient education
Assessment of the potential effect of self-management intervention on patient education, using Health Education Impact Questionnaire (HeiQ), for evaluating the training intervention. Responses to 40 items are marked on a 4-point Likert scale, using the endpoints "strongly disagree/strongly agree". A higher score indicates stronger skills in the management of the chronic condition, except in the emotional distress dimension, which is negatively scored.
Measured: 6 months
Assessment of Functional status
Assessment of the potential effect of self-management intervention on functional status using Modified Medical Research Council Dyspnea Scale (mMRC) to assess dyspnea.The mMRC breathlessness scale ranges from grade 0 to 4. Higher scores indicate greater severity of breathlessness.
Measured: 6 months
Assessement of Patient education
Assessment of the potential effect of self-management intervention on patient education, using Health Literacy Questionnaire (HLQ), assessing literacy.The full HLQ provides nine individual scores based on an average of the items within each of the nine scales. Higher values indicate greater understanding or ability.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start1 Apr 2020
- Primary completion30 Aug 2020
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Crete
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Izolde Bouloukaki, University of Crete
- Investigators
- Ioanna Tsiligianni, Study chair, University of Crete, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05918731
- Sponsor's protocol ID
- COPDSELF-1
- Status last verified
- Jun 2023
- First submitted
- 24 May 2023
- Last updated
- 26 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-management in Chronic Obstructive Pulmonary Disease (COPD) Patients: A Primary Healthcare Intervention Study
- ClinicalTrials.gov ID
- NCT05918731
- Acronym / sponsor ID
- COPDSELF-1
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of CreteUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 26 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of the effectiveness of COPD self-management interventions compared to usual on Quality of life, functional status, patient education, depression, and anxiety in primary healthcare users in the prefecture of Heraklion, Greece.
Detailed description
To the best of our knowledge, no previous study has examined the effects of self-management programs on patients with COPD in Greece. Therefore, the investigators conducted a randomized controlled trial with a post-test design, to evaluate the implementation and clinical effectiveness of a COPD self-management intervention compared to usual care in terms of the following outcomes: Quality of life, functional status, patient education, depression, and anxiety.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care Group | No intervention | –Patients who were assigned to receive usual care were instructed to continue up with their regular medical appointments and their usual check-ups/reviews and if they had any questions, to call the health coach. |
| Self-management Intervention Group | Active comparator | Behavioral: Self ManagementIn the intervention group, a self-management program was implemented. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients aged ≥18 years
- had previously been given a physician-diagnosis of mild COPD
- stable on their medications (no treatment modifications) in the last three months
- able to speak, read and/or understand Greek
Key exclusion criteria (4 listed)
- refusal to participate
- concurrent oncological diseases
- severe cognitive impairment
- neurological, or psychiatric disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self ManagementA "training book" was given to this group, which was created for the study. The implementation process followed a five-step approach including sessions once a month for five consecutive months with a coach and follow-up phone calls after the end of the sessions.To inspire and engage patients, the sessions included a variety of educational techniques, including knowledge transfer, discussion, hands-on training, and homework. Additionally, coaches received training in motivational interviewing methods. The self-management program and all the process of data collection is described in detail on the supplementary file. | Behavioural | Self-management Intervention Group |
Primary outcome
Assessement of Quality of life
Time frame: 6 months
Assessment of the potential effect of self-management intervention on Quality of life using Short-Form Health survey (SF-12) questionnaire. The SF-12 is one of the most widely used instruments for assessing self-reported health-related quality of life. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning
Assessment of Functional status
Time frame: 6 months
Assessment of the potential effect of self-management intervention on functional status using COPD Clinical Questionnaire (CCQ) for clinically evaluating COPD.The Clinical COPD Questionnaire (CCQ) measures health status and can be used to assess health-related quality of life (HRQL). The overall CCQ consists of 10 items that are scored from 0 to 6. The final score is the sum of all items divided by 10. Higher scores indicate a worse health status.
Assessment of Depression
Time frame: 6 months
Assessment of the potential effect of self-management intervention on depression using Beck Depression Inventory, 2nd edition (BDI).The Beck Depression Inventory (BDI) is a 21-item self-reporting questionnaire for evaluating the severity of depression in normal and psychiatric populations.Scores range from zero to 60. Higher total scores indicate more severe depressive symptoms.
Assessement of Anxiety
Time frame: 6 months
Assessment of the potential effect of self-management intervention on anxiety using Beck Anxiety Inventory (BAI). The BAI is a rating scale used to evaluate the severity of anxiety symptoms. The total score ranges from 0 to 63, with higher scores indicating more severe anxiety symptoms.
Assessement of Patient education
Time frame: 6 months
Assessment of the potential effect of self-management intervention on patient education, using Health Education Impact Questionnaire (HeiQ), for evaluating the training intervention. Responses to 40 items are marked on a 4-point Likert scale, using the endpoints "strongly disagree/strongly agree". A higher score indicates stronger skills in the management of the chronic condition, except in the emotional distress dimension, which is negatively scored.
Assessment of Functional status
Time frame: 6 months
Assessment of the potential effect of self-management intervention on functional status using Modified Medical Research Council Dyspnea Scale (mMRC) to assess dyspnea.The mMRC breathlessness scale ranges from grade 0 to 4. Higher scores indicate greater severity of breathlessness.
Assessement of Patient education
Time frame: 6 months
Assessment of the potential effect of self-management intervention on patient education, using Health Literacy Questionnaire (HLQ), assessing literacy.The full HLQ provides nine individual scores based on an average of the items within each of the nine scales. Higher values indicate greater understanding or ability.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ioanna Tsiligianni study chair
University of Crete, Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self Management in people with Chronic Obstructive Pulmonary Disease, run by University of Crete at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessement of Quality of life (time frame: 6 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2023.